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Down SyndromeNCT04801771

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

A study testing Inspire Upper Airway Stimulation (UAS) System in people with Down Syndrome and Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing… Read more about this study

Who is it for?
Ages 10 to 21 years
Conditions the study is for
Down Syndrome, Obstructive Sleep Apnea
What is being tested?
Inspire Upper Airway Stimulation (UAS) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
8 sitesUnited States
Study dates
24 Jun 2021to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of Down syndrome
  • Age 10-21 years
  • Prior adenotonsillectomy
  • Severe OSA (AHI > 10, AHI < 50, no more than 25% AHI attributable to central events) based on prior in-lab PSG performed after adenotonsillectomy and within 18 months of enrollment
  • Approval from at least two of the three physician reviewers based upon the results of a routine drug-induced sleep endoscopy (DISE) having occurred within 12 months of enrollment
  • Subjects must have either tracheotomy or be ineffectively treated with CPAP due to non-compliance, discomfort, un-desirable side effects, persistent symptoms despite compliance use, or refusal to use the device
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  • Children and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative PSG, and questionnaire completion
  • Children's parents/guardians must complete a questionnaire confirming that their child is capable of communicating feelings of pain or discomfort. They must also confirm they are able to assess their child for adverse effects related to device implantation
  • Children and their parents/guardians must be proficient in English

Who cannot join

  • Body mass index (BMI) above the 95th percentile for subject's age
  • Circumferential airway collapse at the level of the velopharynx observed during DISE
  • Other medical conditions resulting in medical instability (eg. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration)
  • Presence of another medical condition requiring future magnetic resonance imaging (MRI) of the chest
  • Patients with another implantable device which could interact unintentionally with the Inspire system
  • Any contraindication for general anesthesia
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  • History of bleeding or clotting disorders and those on blood thinning or NSAID medications for the week prior to implantation surgery. Subjects will be asked to refrain from the use of NSAIDS for two weeks after implantation or any revision surgeries
  • Subject is currently taking muscle relaxant medication
  • Life expectancy less than 12 months
  • Subject's inability to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment
  • Nonverbal candidates will be excluded due to an inability to complete testing procedures including expressive language sampling
  • Subjects with a co-occurring diagnosis of autism spectrum disorder
  • Subjects that have a positive β-HCG
  • Subjects deemed unfit for participation by the investigator for any other reason

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Children's Healthcare of Atlanta/ Emory University School of Medicine

    Atlanta, Georgia, 30329

  • Massachusetts General Hospital (Mass Eye & Ear Infirmary)

    Boston, Massachusetts, 02114

  • Cincinnati Childrens Hospital

    Cincinnati, Ohio, 45229

  • University of Texas Southwestern/Children's Hospital of Dallas

    Dallas, Texas, 75207

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53705

  • Children's Hospital of the King's Daughters/East Virginia Medical School

    Norfolk, Virginia, 32507

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

Read the detailed description

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

Prior to implant subjects will be required to meet eligibility criteria, complete quality of life questionnaires and undergo neurocognitive testing (NCT) and expressive language sampling. Eligibility criteria will be determined via review of medical records, an in-lab polysomnography (sleep study), and a drug-induced sleep endoscopy (DISE).

After implant of the Inspire UAS System, subjects will undergo five (5) study visits. Four (4) of the visits will include an in-lab sleep study (PSG). Follow-up expressive language sampling and neurocognitive testing will be performed at 6 months post-implant. Follow-up quality of life questionnaires will be completed at 12 months post-implant.

Subjects will conclude their participation in the study at the end of their 12 month study visit.

Being tested
Inspire Upper Airway Stimulation (UAS) System
Keywords
Hypoglossal nerve stimulation
Medical subject headings
Down Syndrome, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspire Upper Airway Stimulation (UAS) SystemDevice

    Also called Hypoglossal nerve stimulation

    The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.

Study groups in NCT04801771
Study groupRoleWhat they receive
Subjects implanted with Inspire UAS SystemExperimentalSubjects who meet eligibility criteria will be implanted with the Inspire Upper Airway Stimulation (UAS) System.
Receives: Device: Inspire Upper Airway Stimulation (UAS) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2)

    Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

  2. Change in attention using the Wechsler Intelligence Scale

    Change in Cancellation scaled score of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

  3. Change in processing speed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)

    Change in RTIFMDRT and RTIFMDMT raw scores of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

  4. Change in executive functioning using the Delis-Kaplan Executive Functioning System (DKEFS)

    Change in Category Functioning scaled score of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

  5. Change in learning and memory using the Cambridge Neuropsychological Test Automated Battery - Paired Associates Learning

    Change in PAL-TEA raw score of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

  6. Change in language using Expressive Language Sampling

    Change in % of unintelligible C-units, number of different word roots and mean length of C-units in morphemes of at least 0.5 standard deviation from baseline

    Measured: 6 Months post-implant

Secondary outcomes (3)

  1. Rate of procedure and device-related adverse events

    Procedure and device-related adverse events will be collected in order to profile the safety of hypoglossal nerve stimulation in adolescents. Number and percent of procedure and device-related adverse events will be reported

    Measured: Implant through 12 Months post-implant

  2. Change in Obstructive Sleep Apnea (OSA)

    Change in sleep apnea will be measured using standard in-lab PSG measures including oxygen level, partial and complete airway obstruction, and arousals. Improvement will be defined as a 50% or more decrease in AHI.

    Measured: 3, 6, 12 Months post-implant

  3. Change in quality of life as measured by OSA-18 and ESS-CHAD questionnaires

    Quality of life improvements will be measured using the OSA-18 and ESS-CHAD. Mean scores for each questionnaire will be reported at baseline and 12 months post-implant.

    Measured: 12 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start24 Jun 2021
  3. Primary completion1 Jul 2026
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Hypoglossal Nerve Stimulation
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04801771
Sponsor's protocol ID
2020-003
Other IDs
1U01DC019279-01
Status last verified
Aug 2026
First submitted
15 Dec 2020
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Inspire Upper Airway Stimulation (UAS) System in people with Down Syndrome and Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in intelligence using the Kaufman Brief Intelligence Scale (KBIT-2) (time frame: 6 Months post-implant). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04801771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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